MYCOPHENOLIC ACID for Kidney transplant|Renal insufficiency

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Patient receiving first kidney transplantation"}

Exclusion criteria

• {"criterion_text":"- History of opportunistic infection that required intensive care hospitalization in the two years preceding the transplant\n- Anti-HLA immunization (Flow PRA > or = 20%, presence of donor specific antibody before and/or at time of transplantation and with a positive CDC and FXM with historical and/or transplant day sera)\n- Multi-organ transplant\n- Previous transplant(s)\n- History of cancer\n- Thrombocytopenia < 50 000 platelets\n- Any active infections or Infection with Hepatitis C, B viruses or HIV\n- Pregnant or breast-feeding subjects,"}

Primary endpoints

• {"endpoint_text":"- The primary outcome for the de-escalation study is the DLT defined by a T cell (CD3+) relative depletion above 30 % compared to baseline (Day 0) at the end of the Grafalon® induction treatment (Day 4).","definition_or_measurement_approach":"DLT defined by a T cell (CD3+) relative depletion above 30% compared to baseline (Day 0) measured at the end of Grafalon® induction treatment (Day 4)."}

Secondary endpoints

• {"endpoint_text":"- Toxicities: Incidence and grade for Adverse events (AEs), drug related AEs, drug related AE leading to dose reduction or discontinuation during treatment, SAE and SUSAR, according to CTCAE V5.0.","definition_or_measurement_approach":"Incidence and grade of AEs, drug-related AEs, dose-reduction/discontinuation events, SAEs and SUSARs graded and reported according to CTCAE V5.0."}
• {"endpoint_text":"- Pharmacokinetic study including for each dose level the calculation of the plasmatic clearance evaluated by the AUC of Grafalon® at day 0 and day 4 and the trough level of Grafalon® at each visit until month-3.","definition_or_measurement_approach":"Plasmatic clearance calculated by AUC of Grafalon® at Day 0 and Day 4; trough Grafalon® levels measured at each visit until month 3."}
• {"endpoint_text":"- The absolute count and proportion of different T and B cell subpopulations, NK cells, monocytes and neutrophils at each time point.","definition_or_measurement_approach":"Absolute counts and proportions of specified immune cell subpopulations measured at each scheduled time point."}
• {"endpoint_text":"- Time to Transplant failure defined as the time since transplantation to either graft loss or death with a functioning graft. Return to dialysis or retransplantation defined graft loss. Overall survival defined as the time since transplantation to death. Time to kidney allograft acute rejection defined as the time since transplantation since to kidney allograft acute rejection.","definition_or_measurement_approach":"Time-to-event measures: transplant failure (graft loss or death with functioning graft; return to dialysis/retransplantation = graft loss), overall survival (time to death), and time to acute kidney allograft rejection (time from transplantation to documented acute rejection)."}
• {"endpoint_text":"- The infection up to 1 year after transplantation defined by : -the onset of a severe bacterial infection: all bacterial infections leading to patient hospitalization) -or an opportunistic infection: all types of infections that occur only in patients with an immune system deficiency and never in healthy patients (i.e. pneumocystis, tuberculosis, cryptococcosis, candidosis, Kaposi sarcoma, herpesviridae infections, B EBV lymphoma, HTLV T leukemia, toxoplasmosis, cryptococosis, polyomavirus vir","definition_or_measurement_approach":"Infections up to 1 year post-transplant: severe bacterial infections leading to hospitalization and opportunistic infections as listed (e.g., pneumocystis, tuberculosis, cryptococcosis, candidosis, Kaposi sarcoma, herpesviridae, EBV-related lymphoma, HTLV-related leukemia, toxoplasmosis, polyomavirus, etc.)."}
• {"endpoint_text":"- The atherosclerotic event up to 1 year after transplantation defined by major adverse cardiovascular events (MACE)","definition_or_measurement_approach":"Atherosclerotic events up to 1 year post-transplant defined by occurrence of MACE (major adverse cardiovascular events)."}
• {"endpoint_text":"- The diagnosis of cancer up to 1 year after transplantation defined by all types and stages of post transplant solid organ, cutaneous or hematological malignancies","definition_or_measurement_approach":"Any post-transplant malignancy (solid organ, cutaneous or hematological) of any type or stage diagnosed within 1 year post-transplant."}
• {"endpoint_text":"- Renal function at 1 year post transplant evaluated by estimated glomerular filtration rate (eGFR) calculated by the creatinine clearance according to the formula CKD-EPI : eDFG = 141 x min(Scr/k, 1)α x max(Scr/k, 1)-1.209 x 0.993âge x 1.018 [if female] x 1.159 [if African ethnicity]","definition_or_measurement_approach":"Renal function at 1 year assessed by eGFR calculated using the CKD-EPI formula as specified."}

France

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

30-10-2024

Processing Time Days

16

Number Of Sites

1

Number Of Participants

18

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"CHU de Besançon","duties_or_roles":"Monetary support","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"","full_name":"Neovii Pharmaceuticals AG","duties_or_roles":"Monetary support","organisation_type":""}